Back to results

Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

Primary Purpose

Pelvic Organ Prolapse

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Alfacalcidol 0.0005 MG

Placebo

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Alfacalcidol, MyoD expression, pelvic organ prolapse, vitamin D receptorr, levator ani muscle strength

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

patients with pelvic organ prolapse stages III and IV who underwent surgery at menopausal age
normal BMI
initial serum vitamin D levels <30 ng/mL

Exclusion Criteria:

comorbidities (chronic cough, conspitation)
vitamin D metabolism or immune system interfering diseases or drugs specific routine medications such as anticonvulsants, statin, fibrate or orlistat
history of vitamin D supplementation within the last month

Sites / Locations

Universitas Padjadjaran

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alfacalcidol

Control

Arm Description

Alfacalcidol 0.5 mcg orally given for 3 months

Placebo given orally for 3 months

Outcomes

Primary Outcome Measures

Vitamin D3 levels

Vitamin D3 levels measured using lab tests

Vitamin D receptor levels

Vitamin D receptor levels as assessed by ELISA

Levator ani muscle strength

Levator ani muscle strength as measured using anometry

Secondary Outcome Measures

Full Information

NCT ID

NCT05505253

First Posted

August 15, 2022

Last Updated

August 15, 2022

Sponsor

Universitas Padjadjaran

1. Study Identification

Unique Protocol Identification Number

NCT05505253

Brief Title

Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

Official Title

Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

October 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitas Padjadjaran

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a study performed to evaluate the role of vitamin D supplementation on the strength of levator ani muscle in menopausal women with pelvic organ prolapse

Detailed Description

Forty eight POP women were divided into experimental and control groups in this quasi-experimental study. The experimental group was given 0.5 mcg alfacalcidol orally for three months. We measured levator ani muscle strength, serum 25-hydroxy-vitamin D3 levels, and serum Vitamin D Receptor (VDR) levels at zero months and three months preoperative. Enzyme-linked immunosorbent assay (ELISA) assessed VDR and myoblast determination protein 1 (MyoD) protein expressions in levator ani muscle surgical biopsies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Organ Prolapse

Keywords

Alfacalcidol, MyoD expression, pelvic organ prolapse, vitamin D receptorr, levator ani muscle strength

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alfacalcidol

Arm Type

Active Comparator

Arm Description

Alfacalcidol 0.5 mcg orally given for 3 months

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Placebo given orally for 3 months

Intervention Type

Drug

Intervention Name(s)

Alfacalcidol 0.0005 MG

Intervention Description

Alfacalcidol 0.5 mcg is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo drug is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured

Primary Outcome Measure Information:

Title

Vitamin D3 levels

Description

Vitamin D3 levels measured using lab tests

Time Frame

3 months

Title

Vitamin D receptor levels

Description

Vitamin D receptor levels as assessed by ELISA

Time Frame

3 months

Title

Levator ani muscle strength

Description

Levator ani muscle strength as measured using anometry

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with pelvic organ prolapse stages III and IV who underwent surgery at menopausal age normal BMI initial serum vitamin D levels <30 ng/mL Exclusion Criteria: comorbidities (chronic cough, conspitation) vitamin D metabolism or immune system interfering diseases or drugs specific routine medications such as anticonvulsants, statin, fibrate or orlistat history of vitamin D supplementation within the last month

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RM Sonny Sasotya, Ph.D.

Organizational Affiliation

Universitas Padjadjaran

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitas Padjadjaran

City

Bandung

State/Province

West Java

ZIP/Postal Code

40161

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymised patient data are available upon written request to the authors

IPD Sharing Time Frame

until 31 December 2026

IPD Sharing Access Criteria

Access will be given upon written request to the authorrs

Citations:

PubMed Identifier

31039170

Citation

Zhang L, Quan M, Cao ZB. Effect of vitamin D supplementation on upper and lower limb muscle strength and muscle power in athletes: A meta-analysis. PLoS One. 2019 Apr 30;14(4):e0215826. doi: 10.1371/journal.pone.0215826. eCollection 2019.

Results Reference

result

PubMed Identifier

33935807

Citation

Latham CM, Brightwell CR, Keeble AR, Munson BD, Thomas NT, Zagzoog AM, Fry CS, Fry JL. Vitamin D Promotes Skeletal Muscle Regeneration and Mitochondrial Health. Front Physiol. 2021 Apr 14;12:660498. doi: 10.3389/fphys.2021.660498. eCollection 2021.

Results Reference

result

Learn more about this trial

Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

We'll reach out to this number within 24 hrs